Kornimate/medical-research-clean huggingface dataset:
a real-world study of dexycu in the treatment of inflammation after cataract surgery

Conditions: Inflammation; Cataract

Summary: this is a prospective, real-world study aimed to evaluate the efficacy and safety of dexycu in treating postoperative inflammation of cataracts.

to evaluate the efficacy and safety of dexycu in treating postoperative inflammation of cataracts in real-world clinical settings, medical history and follow-up data from 113 subjects of dexycu group and 150 subjects of external control group will be prospectively collected in hainan, china. additionally, questionnaires will be collected from surgeons on 30 cases to evaluate the difficulty, duration and safety of the dexycu injector.

Eligibility criteria:
inclusion criteria: * subjects must be able to understand and sign the informed consent form and be able to follow the study procedures. * male or female subjects over 40 years of age who are scheduled to undergo cataract phacoemulsification surgery combined with intraocular lens implantation. exclusion criteria: * known hypersensitivity to dexamethasone or any component of the dexycu. * history of intraocular inflammation of any cause in either eye, presence of corneal abnormalities or malnutrition. * have high intraocular pressure, with an iop(intraocular pressure) of \> 21 mmhg in the test eye at screening, regardless of whether receiving anti-glaucoma monotherapy therapy. * posterior capsule rupture or lens dislocation, anterior vitreal membrane rupture, vitreous prolapse and intraoperative floppy iris syndrome during cataract surgery. * other conditions that the investigator considers inappropriate to participate the study.

Keywords: cataract surgery postoperative inflammation
conducting outreach to improve cervical cancer screening rates among underscreened patients

Conditions: Uterine Cervical Neoplasms

Summary: the purpose of this project is to determine whether outreach to hiv-negative patients who are overdue for a pap smear at a new england urban community health center can increase cervical cancer screening rates. it additionally seeks to determine which form of outreach - via letter, email, phone, or a mixture of those modalities- is most effective among these patients.

to the investigators' knowledge, this study will be the first to assess the efficacy of email in cervical cancer screening outreach in a randomized controlled trial. it will also be one of the few randomized controlled trials to directly compare different outreach media directly, as opposed to different variations within a single medium (e.g. two different types of letters). lastly, given the unique patient demographic makeup at fenway, including a significant number of lesbian, bisexual and transgender patients, secondary subanalyses have the potential to significantly add to the investigators' knowledge of what media work best in conducting cervical cancer screening outreach with sexual and gender minorities, who are disproportionately underscreened compared to heterosexual cis-gendered women.

Eligibility criteria:
inclusion criteria: * female or female-to-male transgender patients with a cervix * hiv-negative * medical appointment at fenway community health during calendar year 2012 who have not had a pap smear in the past 3 years (since january 2010) exclusion criteria: * hiv-positive (due to different pap testing guidelines) * male-to-female transgender patients * patients with a history of a hysterectomy, unless specified as partial or supracervical * patients aged 30-64 who had a negative pap test in the past 5 years with simultaneous negative human papillomavirus infection (hpv) co-testing
long-term effectiveness and safety of cp-690,550 for the treatment of rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to determine the long-term effectiveness and safety of cp-690,550 for the treatment of rheumatoid arthritis. subjects are eligible for this study only after participating in another "qualifying" study of cp-690,550 a sub-study will be conducted within the a3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving cp-690,550


Eligibility criteria:
inclusion criteria: * subjects who have participated in a randomized "qualifying" study of cp-690,550 for the treatment of rheumatoid arthritis vaccine sub-study visit * subjects actively participating in study a3921024 must have completed at least 3 months of continuous 10 mg bid cp-690,550 treatment in a3921024 as defined by \>80% compliance with prescribed dose consumption of cp-690,550 over the previous 3 months. exclusion criteria: * serious medical conditions that would make treatment with cp-690,550 potentially unsafe vaccine sub-study visit 1. any documented influenza or pneumococcal infection within the last 3 months prior to randomization in this study 2. received any vaccine within 1 month prior to randomization in this study 3. received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of randomization in this study.

Keywords: long-term open-label safety
clinical and economic benefits of cardiovascular risk management by a dietician in type 2 diabetes patients

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: worldwide, health systems and practitioners are facing obesity epidemics. high blood pressure, dyslipidemia and diabetes prevalence will explode during the 21st century. the two main objectives of this 2-year controlled prospective study are: 1. to demonstrate that, for patients with high blood pressure, diabetes and dyslipidemia, dietician conducted survey and management in combination with annual endocrinologist follow-up enable both attainment and maintenance of recommended blood pressure, glycemic and lipid goals, as well as smoking cessation; 2. to demonstrate that dietician management is more cost effective than conventional care provided by general practitioners and endocrinologists. results are expected to show significantly different cardiovascular risk profiles (bmi and waist circumference, systolic and diastolic blood pressure, ldl-c, triglycerides and total cholesterol/hdl ratio, hba1c, smoking) between baseline and after 2 years follow-up. sample size was determined in order to show statistically significant differences between the two groups. results will document for the benefit of care givers, health economists and policy makers alike an innovative and integrated model of care which is expected to be effective at the patient level as well as cost effective with respect to the increasing financial burden of diabetes on the health system.


Eligibility criteria:
inclusion criteria: * hba1c \> 7% * more than 2 follow-up visits

Keywords: intensive treatment dietician
study of the psychometric properties of two questionnaires for measuring disease flare-up in ibd

Conditions: Chronic Inflammatory Bowel Diseases

Summary: validating two questionnaires for measuring relapse in ibd (crohn's / uc)

ibd (chronic inflammatory bowel diseases) includes crohn's disease and ulcerative colitis (uc). in france, an estimated 300,000 people suffer from ibd (source afa crohn rch france). to our knowledge, there are no patient reported outcomes (pros) validated in french to measure the relapse phenomenon in ibd. such an instrument would complement the available indicators and enable clinicians to detect treatment response at an early stage, as well as failure to respond to treatment, as manifested by the resumption or increased frequency of relapses, and thus enable rapid adjustment of the proposed therapeutic strategy. two questionnaires have been developed, their psychometric properties need to be studied. the project's deliverable will therefore be two validated questionnaires for measuring relapse from the patient's perspective in ibd for routine use. for this reason, the questionnaires will be short, simple to use, easy to interpret and designed to integrate online applications for patient self-monitoring of ibd disease activity.

Eligibility criteria:
inclusion criteria: * patient member of the afa crohn rch, and registered in the mailing list * person having received full information on the organization of the research and not having objected to his/her participation and to the use of his/her data. exclusion criteria: - there were no non-inclusion criteria.

Keywords: psychometric properties patient-reported outcomes
comparison between alpha blocker monotherapy and 5ari monotherapy following combination therapy in benign prostatic hyperplasia (bph)

Conditions: Benign Prostatic Hyperplasia

Summary: this study is designed to investigate the comparison between alpha blocker monotherapy and 5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic hyperplasia.


Eligibility criteria:
inclusion criteria: 1. male aged 45 years old and above (with no upper limit of age) 2. patients who underwent combination therapy of alpha blocker and 5 ari for more than 9 months 3. ipss ≤ 12 4. ability and willingness to correctly complete the micturition diary and questionnaire 5. capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits exclusion criteria: 1. an anticholinergic or antidiuretic if started less than 3 months prior to screening 2. patients who had surgical treatment due to luts 3. patients with suspected neurogenic bladder disorder 4. patients with cancer of any type including cancer of the prostate or bladder 5. patients with urethral stricture or bladder neck contracture 6. patients with suspicious chronic prostatitis/chronic pelvic pain syndrome 7. acute bacterial prostatitis less than 6 months prior to screening 8. symptomatic acute urinary tract infection (uti) less than 1 months prior to screening 9. patients who had underwent prostatic biopsy less than one month prior to screening 10. patients who had unstable angina or cerebral vascular disease less than 6 months prior to screening

Keywords: benign prostatic hyperplasia alpha blocker 5-alpha reductase inhibitor combination therapy
investigation with bioph+psoriasis medical bath in subject with mild to moderate plaque psoriasis.

Conditions: Plaque Psoriasis

Summary: the purpose of this investigation is to assess performance and safety of bioph+ psoriasis medical bath in comparison to a comparative device.

after being informed about the investigation and the potential risks, all subjects giving written informed consent will undergo screening to determine eligibility for study entry. at week 0, subjects who meet the eligibility requirements will be randomised in open, intra-patient investigation, treated with bioph+ psoriasis medical bath on one side, and comparative treatment on the other side for 8 weeks.

Eligibility criteria:
inclusion criteria: * voluntary agreed to participation and has duly signed informed consent form * males and females ≥ 18 years of age * in the investigator's opinion, the patient is not likely to become pregnant during study participation (e.g. in a same-sex relationship, not sexually active, sterile, not of child-bearing age, uses contraception, etc.) * subject diagnosed with stable mild-moderate plaque psoriasis, defined by pasi ≤ 9 * intra-individual difference between left and right hemi-body pasi scores not \> 1.0 * patients with symmetrical psoriasis exclusion criteria: * presence of other forms of psoriasis other than psoriasis vulgaris (palmoplantar psoriasis, inverse psoriasis, other forms of hyperkeratosis) * use of systemic/biological treatment for psoriasis * known hypersensitivity or allergy to study products * any serious medical condition that could interfere with the evaluation of study results * poor compliance in other investigational study, as assessed by investigator * pregnant, breastfeeding, or planning to become pregnant during study * patients with alcohol -or drug abuse * any other conditions as judged by the investigator may make the follow-up or investigation inappropriate * anyone unsuitable to participate as subject according to the declaration of helsinki
safety and efficacy study of evo101 topical cream in atopic dermatitis

Conditions: Atopic Dermatitis Eczema

Summary: this is a phase 2a safety and efficacy study of evo101 for the treatment of adults with atopic dermatitis

this is a phase 2a safety and efficacy study of evo101 topical cream, 0.1%, applied twice daily for 8 weeks in adults with mild-to moderate atopic dermatitis.

Eligibility criteria:
inclusion criteria: 1. males or non-pregnant, non-lactating females, age 18 years or older 2. chronic atopic dermatitis for at least 1 year 3. iga score of 2 or 3 4. bsa of ad involvement of 4-12% 5. easi of 5-20 exclusion criteria: 1. significant ad flare with 4 weeks 2. use of biologic therapy within 12 weeks 3. regular use of tanning booth within 4 weeks 4. skin condition that could interfere with study assessments
safety study of sgx523, a small molecule met inhibitor, to treat solid tumors

Conditions: Advanced Cancer

Summary: sgx523 is a drug which acts by blocking the function of an enzyme called met. met activity may be important in growth and survival of some types of cancer. this phase i trial is studying the safety, side effects, and best dose of sgx523 when given to patients with advanced cancer, and how well it inhibits met activity in tumors.


Eligibility criteria:
inclusion criteria: * subject has the ability to understand, able, willing to comply with study procedures and follow up visits, and has provided written consent. * pathologic evidence of solid tumor. * failed standard therapy and deemed by the investigator to be suitable for participation into the trial. * laboratory values (obtained within 10 days prior to enrollment): anc: \>= 1.5 × 109/l; platelets: \>= 100 × 109/l; hemoglobin: \>= 10.0 g/dl (without transfusions); bilirubin: within normal range; ast, alt, and alkaline phosphatase: \ = 60 ml/min/1.73 m2 for patients with creatinine \> institutional normal values; pt/ptt/inr: within normal limits. * have ihc evidence of phospho-met expression on tumor material no more than 12 months old. this is a requirement only for entry into the mtd dose expansion phase. * have no residual toxic effects of previous therapy, and undergo a washout period of at least 5 half-lives from the time of administration of the previous therapy. exclusion criteria: * pregnant, lactating, or may become pregnant. * cardiac disease requiring medical therapy. * have had a major surgery within 4 weeks prior to day 1 of the study * have an active, uncontrolled bacterial, viral, or fungal infection that requires ongoing systemic therapy. * have a known active infection with hiv, hepatitis b or c. * have psychiatric or seizure disorders that would require therapy or interfere with study participation. * have other severe concurrent nonmalignant disease that could compromise protocol objectives, including malabsorptive conditions. * patients receiving prohibited medications as listed in appendix e, including drugs categorized as strong inhibitors of cyp3a4 and a5 and drugs known to have a high potential risk of liver toxicity. * have known allergy to sgx523 formulation or its excipients (croscarmellose sodium, lactose monohydrate and magnesium stereate). * patients receiving anti-coagulant therapy.

Keywords: solid tumor advanced cancer met inhibitor receptor tyrosine kinase inhibitor (rtki)
aprepitant for the prevention of chemotherapy-induced nausea and vomiting

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: to compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (pda) with antiemetic combination of palonosetron and dexamethasone (pd) in nasopharyngeal carcinoma patients receiving docetaxel, cisplatin, and 5-fu based chemotherapy.

eligible patients will be randomized to receive different antiemetic regimens . in the experimental group,patients will receive aprepitant, palonosetron and dexamethasone .in the other group,patients will accept the same dose of palonosetron and dexamethasone. during the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of cinv,nausea patients will be measured by a visual analogue scale (vas) ,other adverse events should be recorded as well.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. histologically or cytologically confirmed nasopharyngeal carcinoma 3. accept chemotherapy for the first time 4. patients who will receive chemotherapy (docetaxel 60 mg/m2 intravenously (iv), cisplatin 60 mg/m2 iv, and 5-fu (5-fluorouracil) 600 mg/m2 iv) 5. written informed consent exclusion criteria: 1. regnant or breast-feeding 2. uncontrolled psychosis history 3. inability or unwillingness to understand or cooperate with study procedures 4. central nervous system tumors primary or secondary 5. concurrent abdominal radiotherapy 6. history of uncontrolled diabetes mellitus 7. patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma. 8. known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month 9. pre-existing nausea or vomiting 10. inadequate hematological function and abnormal liver and renal function. 11. history of sensitivity to olanzapine 12. concurrent application of quinolone antibiotic therapy 13. treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy. 14. cytochrome p450 3a4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide) 15. concurrent application of systemic corticosteroids 16. active infection or gastrointestinal dysfunction
antimicrobial stewardship through mrsa diagnosis in emergency department (ed) patients with abscesses

Conditions: Cutaneous Abscess

Summary: this study expands upon pilot data for feasibility since may 2011. the study aims to evaluate the effect of rapid test availability on use of targeted spectrum antibiotics for non-mrsa abscesses in ambulatory patients in the emergency department (ed). the multi-institutional study will assess the feasibility of providing the genexpert® mrsa/sa ssti assay to the ed and evaluate the impact of delivering the test result to clinicians in real-time on patient management decisions regarding the use of antimicrobial agents. patients are randomized to standard culture (control arm) or to the genexpert® assay plus standard culture.

our objective was to determine whether real-time availability of rapid molecular results of staphylococcus aureus would impact emergency department clinician antimicrobial selection for adults with cutaneous abscesses. we performed a prospective, randomized controlled trial in two urban emergency departments comparing a rapid molecular test with standard of care culture-based testing. follow-up telephone calls were made at between 2 and 7 days, 1 month, and 3 months after discharge. patients at least 18 years old presenting with a chief complaint of abscess, cellulitis, or insect bite and receiving incision and drainage were eligible. seven hundred seventy-eight people were assessed for eligibility and 252 met eligibility criteria.

Eligibility criteria:
inclusion criteria: * adults 18 years or older with community onset abscess exclusion criteria: * previous treatment for same abscess in past 14 days * postoperative infection * inability to provide informed consent

Keywords: ssti cutaneous abscess boil
rollover study from exg-us-01

Conditions: Telomere Biology Disorders With Bone Marrow Failure

Summary: this is a long-term rollover follow-up study for phase i/ii study (protocol exg-us-01).

patients who received exg34217 treatment and had at least one follow-up visit (month 1, 3, 6, or 12) in study exg-us-01 will be eligible for this rollover study. patient will sign a consent form prior to any study related procedure. this study is to add additional follow-up assessments up to 6 years after exg34217 treatment. this study does not have additional intervention. additional visits will be every 6 months in the first 3 years and once a year for two years.

Eligibility criteria:
inclusion criteria: 1. signed an institutional review board (irb) approved informed consent document indicating that they understand the purpose of, and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. informed consent must be obtained from the subject prior to initiating procedures. 2. have completed the 12-month visit of study exg-us-01. exclusion criteria: -
hypnosedation in relaxing patients undergoing breast cancer surgery

Conditions: Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Prognostic Stage 0 Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8

Summary: this clinical trial studies how well hypnosedation works in relaxing and reducing the need for general anesthesia in patients who are undergoing breast cancer surgery. hypnosedation is a technique that places patients under conscious sedation where they remain awake and numbed during surgery and involves the use of words and images to help patients relax and to affect their thoughts about what is happening during surgery.

primary objectives: i. determine the feasibility of conducting a randomized controlled trial (rct) of hypnosedation (hs) during breast cancer surgery. secondary objectives: i. assess the preliminary efficacy of hs with local anesthesia versus (vs) opioid based general anesthesia (ga) on reducing self-reported anxiety, pain, nausea, vomiting, cancer-related symptoms, and surgical complication rates. ii. preliminarily evaluate changes in immune markers (natural killer cell function, cytokines, and resolution of inflammatory response markers) and endocrine function (epinephrine, norepinephrine, and cortisol). iii. preliminarily identify changes in neurological activity as assessed through electroencephalogram (eeg) activity. iv. preliminarily evaluate the group differences in medical costs. outline: patients are randomized to 1 of 2 groups. group i: patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete. group ii: patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia. after completion of study intervention, patients are followed up at days 1, 3, 5, 7, and 14.

Eligibility criteria:
inclusion criteria: * female clinical stage 0/1 breast cancers patients scheduled to undergo a unilateral, segmental mastectomy +/- sentinel lymph node dissection * able to read, speak, and write english or spanish exclusion criteria: * a significant anxiety disorder * significant pain during core biopsy as reported by the patient * received neoadjuvant chemotherapy, any autoimmune or immunological disease or taking any immune suppression drugs * plastic surgery involvement for oncoplastic reconstruction * if surgery is likely greater than 3 hours